Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac
Reason Presence of particulate matter - Glass like particles.
Ketorolac Tromethamine Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter - found in reserve sample vials at the firm.
What was recalled
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-162-00
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1296-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ketorolac recalls
See all
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Reason Incorrect Product Formulation
Class II · Moderate risk Ongoing
R.E.C.K.
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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